Aldesleukin Imaging in Viewing Tumor Growth in Patients With Stage IV Melanoma Receiving Ipilimumab Therapy

This study is currently recruiting participants.
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Svetomir N. Markovic, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01789827
First received: February 8, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab therapy. New diagnostic procedures, such as single-photon emission computed tomography (SPECT/CT), may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, may carry radiation directly to cancer cells and not harm normal cells. Giving 99mTc-HYNIC-IL2 with SPECT/CT may help find tumor growth in patients with stage IV melanoma


Condition Intervention
Recurrent Melanoma
Stage IV Melanoma
Procedure: scintigraphy
Other: laboratory biomarker analysis
Biological: technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Interleukin-2 Imaging As A Guide To Cancer Immunotherapy (Ipilimumab) In Advanced Melanoma: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Proportion of patients who develop a SLD (grade 2+ allergic reaction; grade 3+ anaphylaxis, grade 2+ injection site reaction, or a grade 3+ non-hematologic toxicity -not attributed to IPI treatment/progression or a co-morbid condition) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
    95% binomial confidence interval will be constructed


Secondary Outcome Measures:
  • Adverse events, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

  • TIL invasion as determined by technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy with tumor burden (as determined by RECIST criteria) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Examined using the Spearman rank correlation coefficients.

  • Tumor based biomarkers, and peripheral blood biomarkers [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Spearman rank correlation coefficients will be used.


Estimated Enrollment: 12
Study Start Date: March 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (scintigraphy)
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab therapy and at 12 weeks.
Procedure: scintigraphy
Undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphies
Other: laboratory biomarker analysis
Correlative studies
Biological: technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2
Undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphies
Other Name: 99mTc-HYNIC-IL2

Detailed Description:

PRIMARY OBJECTIVES:

I. Feasibility/biodistribution of 99mTc-HYNIC-IL2 (technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin 2) scintigraphy in patients with metastatic melanoma undergoing ipilimumab (IPI) therapy.

SECONDARY OBJECTIVES:

I. Correlation of tumor infiltrating lymphocyte (TIL) invasion (scintigraphy/histology) with tumor diameter (Response Evaluation Criteria in Solid Tumors [RECIST]); description of survival end points(progression free survival [PFS]/overall survival [OS] and 2 year survival rate); and description of any clinical side effects associated with imaging.

TERTIARY OBJECTIVES:

I. Correlation of TIL invasion assessed by 99mTc-HYNIC-IL2 scintigraphy vs histology (total and subsets of TIL), as well as screen for peripheral blood correlates.

OUTLINE:

Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab therapy and at 12 weeks.

After completion of study treatment, patients are followed up every 3 months for up to 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic proof of stage IV melanoma (pathology report confirmation) with plans to initiate therapy with ipilimumab according to Food and Drug Administration (FDA) approved guidelines with multiple lesions such that

    • Two of these lesions are in the same organ and at least one of these two lesions is measurable by CT imaging according to RECIST 1.1 OR
    • Three of these lesions are in different organs and at least one of these 3 lesions is measurable by CT imaging according to RECIST 1.1
  • Patient eligible for and will be receiving ipilimumab as standard of care therapy
  • At most 2 prior systematic regimens in the metastatic setting
  • Absolute neutrophil count (ANC) >=1500 mL
  • Hemoglobin (Hgb) > 10 g/dL
  • Platelets (PLT) >= 50,000 mL
  • Aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
  • Alkaline phosphatase =< 3 x ULN*; *up to 5 x allowed for patients with liver metastases
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester for follow-up
  • Life expectancy >= 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • For women of childbearing potential, a negative serum pregnancy test =< 7 days prior to registration
  • Willingness to participate in mandatory imaging studies as well as provide mandatory blood samples for correlative research
  • Tumor accessible for biopsy

Exclusion Criteria:

  • Uncontrolled or current infection
  • Known allergy to 99mTc-HYNIC-IL2 or components
  • Any of the following prior therapies with interval since most recent treatment:

    • Chemotherapy =< 3 weeks prior to registration
    • Biologic therapy =< 3 weeks prior to registration
    • Radiation therapy =< 3 weeks prior to registration
  • No more than 3 prior systematic regimens in the metastatic setting
  • Failure to fully recover from side effects of prior chemotherapy or surgery
  • Any of the following, as this regimen may be harmful to a developing fetus or nursing child:

    • Pregnant women
    • Nursing women
    • Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789827

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Svetomir N. Markovic    507-538-7623    markovic.svetomir@mayo.edu   
Principal Investigator: Svetomir N. Markovic         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Svetomir Markovic Mayo Clinic
  More Information

No publications provided

Responsible Party: Svetomir N. Markovic, M.D., Ph.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01789827     History of Changes
Other Study ID Numbers: MC1274, NCI-2013-00297
Study First Received: February 8, 2013
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Interleukin-2
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014